When our children become deniable guinea pigs

Tuesday, December 05, 2017 Stef dela Cruz 0 Comments

I am about to tell you how the dengue vaccine program broke my heart. Bear with me as I wax emotional about a tragedy I saw coming but couldn’t stop.

One year and nine months ago, I wrote a carefully-crafted dengue vaccine article for MIMS that advised caution even as it stayed optimistic, given how children who received it were at a greater risk for severe disease compared to those who didn’t. I wasn’t alone in my fears after colleagues saw the evidence.

Despite fair warning from health experts, the Philippine government procured the vaccine, showing telltale signs of strong-arm tactics, for a vaccine program targeting 1 million school children. The program cost a staggering PHP 3.5 billion – almost twice as much as what was spent for a preexisting comprehensive immunization program against hepatitis B, tetanus, tuberculosis, polio, diphtheria, pertussis, and measles, available to all qualified members of the pediatric population.

Children were immunized even as the dengue vaccine trials were still ongoing.

dengue vaccine

Five days ago, Sanofi released a statement finally admitting that the dengue vaccine they sold to the Philippines may lead to a severe form of dengue in those without prior infection.

Oddly enough, the drug group denied turning our children into guinea pigs.

 

Sad to be right

I am so tempted to tell Sanofi, “I told you so.” In fact, many others told you so. Filipino doctors, scientists – and even Dr. Scott Halstead, noted dengue researcher who coined the term antibody-dependent enhancement, a unique and potentially deadly reaction to dengue infection – warned against the dengue vaccine due to signals of harm evident in previous studies.

But I won’t say it. It feels awful to be right.

Warnings fell on deaf ears as money talked louder. After the vaccine program pushed through, Sanofi even partnered with Watsons to provide dengue vaccination on a commercial basis, despite orders from the Food and Drug Authority to halt marketing.

While Sanofi and the government officials who pushed for the dengue vaccine program deserve all the shade coming their way, I can’t seem to find the energy to gloat. I was right. My colleagues were right. But at what price? The lives of innocent children?

In this war of wills, the children lose. Do any of us really want to win?

 

700,000 lives too late

Sanofi’s statement, coming at the heels of a long-overdue change in vaccine label, is one year and nine months too late. Hundreds of thousands of Filipino children have already been given the vaccine. It would be difficult to figure out who among them never had dengue in the past, because an initial dengue infection can have nonspecific symptoms. Testing the serologic status is expensive and, in this case, one vaccine – and 700,000 lives – too late.

Because of a vaccine prematurely approved for use while it was still undergoing Phase IV trials, these children will be at risk for potentially-lethal severe dengue for an indefinite period of time.

Checks and balances existed to ensure the safety of the people. Regrettably, these were set aside to ensure the vaccine was included in the formulary, approved for use, and procured with a multibillion price tag not even remotely proportionate to the disease burden it hoped to relieve.

Several deaths post-vaccination have allegedly been reported. What happens now? Who will be held accountable for any loss of life?

What do we do as a people after we realize that our children have become deniable guinea pigs for an allegedly-corrupt experiment masquerading as a vaccine program?

 

No immunity to blame

Label changes are not enough. Adding salt to the wound, press statements that prioritized deniability over liability are a travesty of the apology we demand and deserve.

We need to seek justice, just as much as we need to grieve. Sanofi and the government officials who kowtowed to them can no longer put lipstick on this ugly pig.

But they are not the only ones accountable for this sad scam of an experiment. While health advocates continue to fight and give hope, a war against corruption and death cannot be fought without the active involvement of the entire medical community.

There should never have been recommendations until there was enough information. There should never have been immunization schedules released by medical societies that included the dengue vaccine until its safety was certain.

Doctors now find themselves in a dilemma, wondering what to do after giving vaccines to patients who were never tested for previous dengue exposure. The government has rightfully suspended the distribution and sale of the dengue vaccine, but now finds itself the subject of a public backlash.

Nobody is immune to blame in this catastrophe of a vaccine program.

This is, plain and simple, a sad controversy involving political and pharmaceutical giants; a health tragedy colored by politics and money that breaks the heart of every Filipino forced to witness the disinclination to accountability.

Dengvaxia

We are all in this together. We have to join forces and pick up the pieces. We have to move on and figure out how to protect our children from further harm. But we have to uncover the truth and hold people responsible to ensure this will never happen again.

And the next time you hear of some really vocal health advocates openly criticizing a new drug or vaccine, I hope you join the conversation. We should all speak up, ask questions, and exercise discretion.

Silence is agreement. Neutrality is endorsement. Don’t our children deserve better?

Stef dela CruzAbout the blogger
Stef dela Cruz is a doctor and writer. She received the 2013 Award for Health Media from the Department of Health. She maintains a health column in Health.Care Magazine and a cat welfare column in The Manila Bulletin's Animal Scene. Add her to your circles.

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